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A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: DAXI 12 U | Experimental | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
|
| Cohort 2: DAXI 24 U | Experimental | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
|
| Cohort 3: DAXI 36 U | Experimental | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
|
| Cohort 4: DAXI 48 U | Experimental | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaxibotulinumtoxinA for injection | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With None or Mild in LCL Severity at Maximum Smile | Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale | Week 4 After LCL Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento, CA Site | Sacramento | California | 95816 | United States | ||
| Sarasota, FL Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: DAXI 12 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| FG001 | Cohort 2: DAXI 24 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2019 | Jun 1, 2023 |
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| Sarasota |
| Florida |
| 34239 |
| United States |
| Itasca, IL Site | Itasca | Illinois | 60143 | United States |
| Arlington, VA Site | Arlington | Virginia | 22209 | United States |
| FG002 | Cohort 3: DAXI 36 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| FG003 | Cohort 4: DAXI 48 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| COMPLETED |
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| NOT COMPLETED |
|
Intent to treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: DAXI 12 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| BG001 | Cohort 2: DAXI 24 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| BG002 | Cohort 3: DAXI 36 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| BG003 | Cohort 4: DAXI 48 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With None or Mild in LCL Severity at Maximum Smile | Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale | LCL Evaluable | Posted | Count of Participants | Participants | Week 4 After LCL Treatment |
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The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: DAXI 12 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | 0 | 15 | 0 | 15 | 6 | 15 |
| EG001 | Cohort 2: DAXI 24 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | 0 | 17 | 1 | 17 | 7 | 17 |
| EG002 | Cohort 3: DAXI 36 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | 0 | 15 | 0 | 15 | 7 | 15 |
| EG003 | Cohort 4: DAXI 48 U | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | 0 | 16 | 0 | 16 | 6 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mastitis | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Blepharospasm | Eye disorders | Systematic Assessment |
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| Eye pruritus | Eye disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Injection site bruising | General disorders | Systematic Assessment |
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| Injection site erythema | General disorders | Systematic Assessment |
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| Injection site oedema | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Injury associated with device | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Ear infection | Infections and infestations | Systematic Assessment |
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| Herpes zoster | Infections and infestations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Localised infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Blood glucose increased | Investigations | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | Systematic Assessment |
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| Neutrophil count increased | Investigations | Systematic Assessment |
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| Neutrophil percentage increased | Investigations | Systematic Assessment |
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| Weight increased | Investigations | Systematic Assessment |
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| White blood cell count increased | Investigations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Ingrowing nail | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
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The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i)to provide Revance with the opportunity to review and comment on the contents thereof, (ii)to identify any Confidential Information to be deleted from the proposed publication or disclosure, and (iii)or delay the publication or disclosure 90 days to allow Revance to pursue patent protections.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Gross, PhD, VP, Clinical Development & Data Science | Revance Therapeutics, Inc. | 510-742-3400 | tgross@revance.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2020 | Jun 1, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black/African American |
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| White |
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| Other |
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